BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW 3-L CVC KIT: 7 FR X 20 CM

    MDR report key: 10017085 · Received May 1, 2020

    Report

    Report Number
    9680794-2020-00194
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    February 21, 2020
    Report Date
    April 16, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    ACCORDING TO THE MAUDE REPORT (MDR REPORT KEY 9883244 AND MEDWATCH# 5093936-NOT RECEIVED AT THIS TIME BUT THE DOCUMENT NUMBER IS REFERENCED ON THE MAUDE REPORT) "PT HAD A TRIPLE LUMEN ARROW CENTRAL LINE IN PLACE WITH THE SECOND SITE ADJUSTABLE HUB AND CATHETER CLAMP UTILIZED TO HOLD THE LINE IN PLACE. WHEN WET/DAMP/CLEANED THE CENTRAL LINE EASILY MOVES OUT OF THE SECOND SITE ADJUSTABLE HUB AND CATHETER CLAMP. ON THIS PT, THE CENTRAL LINE INADVERTENTLY FELL OUT WHEN IT GOT WET. THIS IS THE SECOND PATIENT THIS HAS OCCURRED IN AND AN ADDITIONAL MEDWATCH WILL BE FILLED FOR THAT PATIENT".

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS NO CUSTOMER CONTACT INFORMATION AVAILABLE AT THIS TIME THEREFORE THE CUSTOMER CANNOT BE CONTACTED FOR ADDITIONAL INFORMATION. IF OR WHEN THE CUSTOMER CONTACT INFORMATION IS PROVIDED THE CUSTOMER WILL BE CONTACTED WITH ADDITIONAL QUESTIONS.

    Description of Event or Problem · 1

    ACCORDING TO THE MAUDE REPORT (MDR REPORT KEY 9883244 AND MEDWATCH# 5093936 -NOT RECEIVED AT THIS TIME BUT THE DOCUMENT NUMBER IS REFERENCED ON THE MAUDE REPORT) "PT HAD A TRIPLE LUMEN ARROW CENTRAL LINE IN PLACE WITH THE SECOND SITE ADJUSTABLE HUB AND CATHETER CLAMP UTILIZED TO HOLD THE LINE IN PLACE. WHEN WET/DAMP/CLEANED THE CENTRAL LINE EASILY MOVES OUT OF THE SECOND SITE ADJUSTABLE HUB AND CATHETER CLAMP. ON THIS PT, THE CENTRAL LINE INADVERTENTLY FELL OUT WHEN IT GOT WET. THIS IS THE SECOND PATIENT THIS HAS OCCURRED IN AND AN ADDITIONAL MEDWATCH WILL BE FILLED FOR THAT PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482169 ARROW 3-L CVC KIT: 7 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 13F19E0655

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN.| UNKNOWN.